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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K251847

510(k) cleared

Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

Sleepnet Corporation · Jan 15, 2026 · K251847

FDA cleared the Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask from Sleepnet Corporation on Jan 15, 2026 under K251847, a traditional 510(k). The device falls under product code BZD, Ventilator, Non-Continuous (Respirator), regulated at 21 CFR 868.5905 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jun 16, 2025. The decision came 213 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Sleepnet Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251847?

K251847 is the FDA 510(k) for Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask, submitted by Sleepnet Corporation. FDA's decision date was Jan 15, 2026, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask?

Sleepnet Corporation, based in Hampton, NH, is the applicant of record for K251847.

How long did the K251847 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on Jan 15, 2026, 213 days later.

← All decisions in January 2026